Quantaforte

GUDID 08033945934699

Intense Pulsed Light handpiece 580-950 nm HR

QUANTA SYSTEM SPA

Light-energy skin surface treatment system applicator

• Primary Device ID: 08033945934699
• NIH Device Record Key: 1aabb9ae-9e51-4d5d-b2c2-0bab661e8ef5
• Commercial Distribution Discontinuation: 2018-11-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Quantaforte
• Version Model Number: OAM001907
• Company DUNS: 436045833
• Company Name: QUANTA SYSTEM SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033945934699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152714

FDA Product Code

• ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-01
• Device Publish Date: 2016-08-29

On-Brand Devices [Quantaforte ]

• 08033945934743: Laser diode handpiece 808 nm
• 08033945934729: Nd:YAG laser handpiece 1064 nm
• 08033945934712: Intense pulsed light handpiece 635-950 nm
• 08033945934705: Intense Pulsed Light handpiece 580-950 nm SR
• 08033945934699: Intense Pulsed Light handpiece 580-950 nm HR
• 08033945934682: Intense Pulsed Light handpiece 535-950 nm
• 08033945934675: Intense Pulsed Light handpiece 415-950 nm
• 08033945934736: 2940 nm Erbium:YAg handpiece